Effect of Anu Tail Nasya on the nasal bacterial micro flora in Healthy volunteers
- Conditions
- Healthy Human Volunteers to check effect of Anu Tail Nasya
- Registration Number
- CTRI/2017/05/008527
- Lead Sponsor
- Deepak M Vyas
- Brief Summary
**Study design**
This study was a randomised parallel group clinical trial to study the effect of *Anu Tail Nasya* on healthy volunteers with the help of normal nasal bacterial micro-flora. There were two groups one intervention group i.e., Group A receiving Anu Tail Nasya therapy for seven days and second group i.e., Group B without any intervention.
**Hypothesis**
The study was conducted to observe the effect of Anu tail Nasya on nasal bacterial flora whether Anu tail Nasya will help to maintain commensal bacterial flora and also it will reduce pathogenic bacteria flora.
**Sampling Technique**
The volunteers were selected irrespective of their sex, religion, and occupation etc., The Simple random sampling method(lottery method) was adopted for grouping.
**Design**
Parallel-Group Randomized clinical trial
The study had received prior approval from the Institutional ethics committee.
(Ref. No. MAM/SS Ayu/711 Date 29/12/2010)
**Sample size**After screening, 100 volunteers filter through following criteria
**Methods:-**
1. **Screening of volunteer: -**Volunteers were screened with the help of screening form**.** The screening proforma consist of inclusion and exclusion criteria. The Health status of the volunteer was decided with the help of Health status form. It includes the *Charakokta* and *Kashyapokta Swastha Lakshana*. Those fulfilled the above criteria was investigated for complete blood count. The screened volunteers having complete Blood count within normal range were enrolled for further study after signing informed consent.
**2.** **Ethical consideration and informed Consent:-**
The eligible volunteers were fully informed about the study in their own first language. The researcher freely obtained written informed consent of the volunteer for their participation in the study. The consent form was fully explained to the Volunteer. The Volunteer was given ample opportunity to ask questions and be assured that non-participation in the study would not compromise any right and, once enrolled the volunteer could withdraw consent or to be discontinued from the study at any point.
§ Enrollment day was considered as ’ day 0’ and baseline information were collected. After the enrollment, each volunteer was given a separate ID form to hide their identity.
3. Enrolled volunteers were randomly allocated into two groups i.e.Group A and Group B with the help of lottery method.
**4.** **Grouping of Volunteers**
**Group A-** Intervention group
§ Number of volunteers- 50
§ *Anu Tail Nasya* therapy for seven days
§ Route of *Dravya* Administration-Nasa
§ Dose of Nasya- 8 drops in each nostril followed by *Gandusha*
§ Nasal swab was obtained on day 0 (baseline), 10th day and 20th day from the day of enrollment.
**Group B-**Control group
§ Number of volunteers- 50
§ No intervention
§ Nasal swab was obtained on day 0 (baseline), 10th day and 20th day from the day of enrolment.
**Scheduled follow-up**
§ 0 day – Enrolment day
§ 10th Day - 1st follow up
§ 20th Day - 2nd follow up
**Culture Technique**:- The culture technique was performed according to technique mentioned in **Mackie (1).**
**Culture Report Result**
The result of microbial study was compiled under three groups i.e. **I) Major component of normal nasal flora, II) Common sinus pathogens and III) other bacteria.** The group of major component of normal flora includes α-hemolytic streptococci, Coagulase-negative staphylococci, Coagulase positive staphylococci. II) Common sinus pathogen is β- hemolytic streptococci. III) Other bacteria include Bacillus subtilis, Enterobacteriaceae species (It includes E. coli, K. pneumoniae and P. mirabilis), Pseudomonas and Nonhemolytic streptococci.
**Unscheduled follow-up**
Volunteers who came at study centre other than their actual scheduled follow-up for any complaints considered as unscheduled follow- up.
**Serious adverse events (SAE)**
If any Serious Adverse Events happened then, it will be recorded and immediately reported to the Ethics Committee.
**Drop out criteria:-**
**1.** **Voluntary withdrawal of consent (VW)** – Volunteer not willing to continue his participation in the study and expressed their desire to withdraw consent at any time in the study period.
**2.** **Moved out of study area (MO)** – If the Volunteer expressed his desire to discontinue the study and was not willing to follow up because he shifted from his current residing place and moved out of the study area beyond 50kms from the study site.
**3.** **Lost to follow-up (LTF)** - Any Volunteer who did not turn up at the study centre on schedule visit and could not be traced on home visit/cell phone contact was considered as lost to follow-up.
**4.** If any serious adverse events (SAE)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- 1.Healthy individual 2.Individual of either sex i.e. Male or Female 3.Age:.
- 20 – 40 yrs 4.Volunteers residing in study area since last 15 days & not planned to go away in next 15 days after Nasya Karma 5.Willing for consent.
1.Volunteers with addiction of smoking & chronic Alcohol intake 2.Volunteers participated in any other clinical trial 4 weeks prior to enrolment into this study 3.Volunteer with family history of Congenital or hereditary disorders 4.Volunteer with history of any acute or chronic medical or surgical illness 5.Volunteer with history of any nasal or systemic medication in last 4 weeks 6.Volunteer with history of Panchakarma Vyapad 7.Volunteer with history of travelling in last 4 weeks 8.Pregnant & Lactating women 9.Volunteer with acute or chronic clinically significant pulmonary, cardiovascular, genitourinary or any systemic abnormality as determined by history or clinical examination 10.Volunteer with Nasya karma Ayogya.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Effect of Anu Tail Nasya on major component of commensal nasal bacterial micro-flora 2 months 2.Effect of Anu Tail Nasya on common sinus pathogen of nasal bacterial micro-flora 2 months
- Secondary Outcome Measures
Name Time Method Effect of weather on nasal bacterial micro-flora in healthy volunteers 2 months
Trial Locations
- Locations (1)
MAMs Sumatibhai Shah Ayurved Mahavidhyalaya
🇮🇳Pune, MAHARASHTRA, India
MAMs Sumatibhai Shah Ayurved Mahavidhyalaya🇮🇳Pune, MAHARASHTRA, IndiaDr Deepak M VyasPrincipal investigator09404554773dr.deepakmvyas@gmail.com